August 14, 2013
FoREMS & More: FDA Meeting on REMS Standardization and Evaluation
On July 25-26, 2013, FDA held a 2-day public meeting to obtain input on issues and challenges associated with the standardization and evaluation of Risk Evaluation and Mitigation Strategies (REMS) for drugs. FDA staff provided updates on their efforts to improve the standardization and evaluation of REMS, while dozens of speakers representing the biopharmaceutical industry, healthcare providers, patient advocacy, and other stakeholders provided recommendations for FDA consideration. The key themes and recommendations discussed at this meeting are important considerations for risk management professionals worldwide.
- Overview of meeting events
- Recap of recurring themes and insightful recommendations
- Identify important trends
- Jeff Fetterman - President, ParagonRx
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